HEARTSTART MRX Adverse Event — Malfunction (MDR 1218950-2020-02532)
HEARTSTART MRX Adverse Event — Malfunction (MDR 1218950-2020-02532) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTSTART MRX; Generic name: DEFIBRILLATOR; Manufacturer: PHILIPS MEDICAL SYSTEMS.
| Device | HEARTSTART MRX |
|---|---|
| Generic name | DEFIBRILLATOR |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Report number | 1218950-2020-02532 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | IT WAS REPORTED THAT THE CO2 FAILS THE OPERATIONAL CHECK; THE INLET AND OUTLET LEAKAGE TEST FAILS. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. |
| Source | openFDA MAUDE (device adverse events) |
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